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Purple Book reference family · 351(a) biologic

epoetin alfa (Epogen/Procrit)

epoetin alfa is an FDA-licensed reference biologic from Amgen Inc., with 1 approved follow-on biologic.

351(a) biologicBLA 103234 Amgen Inc.
Biosimilars
1
Interchangeables
0
Listed patents
0
Reference approved
—

Reference product

Originator biologic
351(a)BLA 103234

Epogen/Procrit epoetin alfa

Also under this BLA: Procrit

Amgen Inc.

View full reference-product record
Approved
Not listed
Marketing
Rx
Center
CDER
Patents
None listed

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for epoetin alfa from the RCSB Protein Data Bank (PDB 1BUY).

3D molecular structure of epoetin alfa (PDB entry 1BUY)

Interactive biological assembly from PDB entry 1BUY. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here, with no need to leave the page.

Open in RCSB viewer PDB 1BUY details

Exclusivity & patent cliffs

Protection horizon

  1. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    29 yr 2 mo ago

Biosimilars & interchangeables for epoetin alfa

Follow-on biologics
Biosimilars and interchangeable biosimilars referencing epoetin alfa.
ProductProper nameApplicantTypeBLAApproved
Retacritepoetin alfa-epbxHospira Inc., a Pfizer CompanyBiosimilar 351(k)125545

epoetin alfa: frequently asked questions

Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.

Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for epoetin alfa.

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